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Hospital is only Florida site where the alternative to open-heart surgery clinical trial is available

A few days after a revolutionary minimally invasive heart procedure was performed at University of Miami Hospital, the two patients were up-and-about and getting back to their regular activities. The procedure, a percutaneous valve replacement performed using catheters, is a new option for some older people who suffer from aortic stenosis but would not normally be treatable because they would be unable to withstand open-heart surgery and a long recovery period.

The disease, a narrowing of the valve that restricts blood flow, is a function of aging and has a high mortality rate if not treatable.

The new procedure, an FDA-approved clinical trial that is available at a handful of select facilities across the nation and only at UM in Florida, launches a “new era in the management of heart disease,” said William O’Neill, M.D., the Miller School’s executive dean for clinical affairs, who, along with Alan Heldman, M.D., clinical chief of the Cardiovascular Division, implanted the new heart valves.

“These patients were both treated with catheters and you can see they both look fantastic about five or so days after the procedure,” O’Neill said at an April 24 news conference where the patients, Harold Schoendorf, 81, of Coral Gables, and Kenneth Horstmyer, 86, of Key Biscayne, were animated as they described how, just days after undergoing the procedure, they no longer felt short of breath or displayed symptoms of fatigue.

“I walked about a good half mile yesterday. Everything is fine,” said Schoendorf, who still directs Miami-Dade County’s building department’s mechanical division and hopes to return to work next week. He is also planning to resume traveling (possibly a return trip to China), and swimming, an activity that became too strenuous before his valve replacement.

Horstmyer, who underwent open-heart surgery 22 years ago, says with the exception of extreme fatigue, he didn’t feel he suffered “the classic symptoms” of aortic stenosis. The retired Burger King executive vice president initially sought treatment at a the Cleveland Clinic in Ohio in December 2006 but turned to UM when he learned of Dr. O’Neill and the percutaneous valve trial.

Asked how he felt now, Horstmyer laughingly said he hadn’t tested the results with vigorous exercise but “that will come…certainly I feel fine.”

The minimally invasive procedure is an important medical advance because nearly half of the 200,000 Americans who need a new heart valve do not get them. It is just one example, Heldman remarked, that shows UM’s commitment to becoming a nationally recognized destination for vascular care. The University recently expanded the department and hired several renowned heart and vascular physicians and researchers from the top programs in the country.

“Vascular disease is certainly an area the where the University of Miami is devoting a great deal of effort and resources to develop a world-class program,” Heldman said. “Patients with complex problems no longer need to leave Florida to get to the best doctors.”

In 2005, O’Neill performed the first percutaneous valve replacement in the United States. Outside the United States, the first such replacement procedure was done in France in 2002. O’Neill has followed these cases and noted there have been no failures of the device. It is, however, not recommended for all patients.

The Edwards SAPIEN heart valve was developed by Edwards Lifesciences specifically for patients with severe aortic stenosis who are high risk or not candidates for conventional open-heart valve surgery.

In severe aortic stenosis, Heldman explained, the normally flexible “leaflets” that eject blood from the heart become hardened and narrow, restricting blood flow and creating a murmur, processes the new valve was able to reverse.

“It is remarkable that the degree of obstruction we saw was completely relieved immediately after the procedure,” Heldman said. “Not only did the patients feel well, they had no heart murmur.”